Download the presentation here: PDF

A New, and Better Opioid from J&J / Grunenthal
44
FDA Approves Tapentadol for Moderate to Severe Acute Pain
November 25, 2008 — The US FDA has announced approval of tapentadol hydrochloride (Johnson &
Johnson/Grunenthal), an immediate-release oral tablet for the relief of moderate to severe acute pain.
The drug acts as both an opioid and nonopioid agent, the FDA release notes. It acts primarily as a
mu-opioid-receptor agonist but also inhibits reuptake of norepinephrine, which may also have
an analgesic effect.
A statement from Johnson & Johnson notes that following this FDA approval, "as per federal
regulation for all controlled substances, tapentadol will be reviewed by the US Drug Enforcement
Administration for scheduling, and it cannot be sold until it receives a scheduling classification."
The approval was based on data from clinical studies involving more than 2100 patients, the Johnson
& Johnson release notes. These phase 3 studies, presented at the 27th Annual Scientific Meeting of
the American Pain Society in May, showed significant relief compared with placebo for patients
undergoing bunionectomy, a common foot surgery; in pain from end-stage joint disease; and with low
back pain or osteoarthritis of the hip or knee. It was generally well tolerated.
The most common adverse effects from tapentadol are nausea, dizziness, vomiting, sleepiness, and
headaches, the FDA release said. "The labeling for tapentadol includes warnings about the risk of
respiratory depression; addictive depressive effects on the central nervous system when taken with
alcohol, other opioids, or illicit drugs; and abuse potential," the FDA release adds.
DEA scheduling review is expected by late Feb 09.
Company press release
© Defined Health, 2009
Pain Insight Briefing